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Regulatory Affairs Director

2 months ago


Singapore HARPS GLOBAL PTE. LTD. Full time
Regulatory Affairs Leadership Opportunity

HARPS Global Pte Ltd is seeking a seasoned Regulatory Affairs professional to lead our global team and drive regulatory compliance across our worldwide offices.

This role will require managing a global team and approximately 25% travel is expected.

Key Responsibilities:
  1. Develop and implement global policies for worldwide offices, ensuring consistency and compliance with regulatory requirements.
  2. Stay abreast of evolving regulatory trends and best practices, providing strategic direction and insight on local and regional regulatory issues.
  3. Identify and address regulatory risks and opportunities to facilitate business growth, collaborating with global counterparts to ensure regulatory compliance.
  4. Serve as the Subject Matter Expert, presenting regulatory reports, summaries, and updates to the senior management team.
  5. Collaborate with cross-functional teams to ensure all products comply with safety and regulatory requirements, consistent with commercial requirements.
  6. Represent HARPS Global Pte Ltd as the regulatory spokesperson on regulatory issues and developing legislation, aligning with business directions.
  7. Participate in internal and external audits to ensure regulatory compliance, maintaining and updating regulatory authorizations, licenses, and certifications.
  8. Supervise, lead, and manage a team of regulatory affairs and quality assurance experts to support business growth.
Requirements:
  • Bachelor's degree or equivalent.
  • Certification in regulatory affairs is a plus.
  • Minimum 10 years of experience in regulatory affairs, with deep industry knowledge relevant to the company's business environment.
  • Track record of business partnership to help build growth.
  • Strong understanding of global legal and regulatory requirements and guidelines.
  • Excellent interpersonal skills, with the ability to engage effectively with diverse stakeholders.
  • Strategic mindset, analytical thinking, and sound judgment in complex decision-making situations.